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Current clinical practices often provide general verbal advice to low-risk patients, which may not sufficiently address individual concerns or offer actionable steps. Generic information on the internet can be overwhelming or unreliable, leading to confusion and unnecessary follow-up visits.
This project introduces a tailored approach by combining evidence-based guidelines with personalized details about the patient's risk profile. The discharge letter bridges the gap between clinical expertise and patient understanding, offering clear, specific, and actionable advice that has been shown to improve health behaviors and outcomes in other contexts .
The personalized discharge letters are generated using an AI agent trained on validated letters from the hospital's electronic health record system (KWS). Each letter is reviewed and approved by a physician before being provided to the patient, ensuring both accuracy and clinical relevance.
This study is a prospective, parallel-group, open-label, randomized controlled trial designed to evaluate the impact of a personalized discharge letter-with or without digital visual support -on reassurance, knowledge, and self-management in low-risk skin cancer patients following dermatological screening.
Study Arms: Participants will be randomly assigned to one of three groups:
Scientific Rationale Current discharge practices for low-risk skin cancer patients often rely on general verbal advice, which may not sufficiently address individual concerns or promote long-term self-care. Evidence from other medical domains suggests that personalized communication improves patient understanding, satisfaction, and adherence to follow-up recommendations.
This study introduces an AI agent trained on validated discharge letters from the hospital's electronic health record system (KWS). The AI helpt collect information from the electronic health record that is relevant for creating personalized letters that are reviewed by a physician before being provided to the patient. These letters aim to improve understanding of personal skin cancer risk, sun protection, and self-monitoring practices.
The addition of visual digital support (IntelliStudio) is hypothesized to further enhance patient engagement and confidence by providing clear, visual explanations of findings and next steps. This design allows for a direct comparison of standard care versus increasingly personalized interventions, enabling the evaluation of both individual and combined effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Standard of Care | Active Comparator | Verbal information only. |
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| Group B: Personalized Discharge Letter | Experimental | Tailored written information based on individual risk profile, skin type and consultation findings. |
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| Group C: Personalized Discharge Letter + Digital Visual Support (IntelliStudio) | Experimental | Tailored written information plus digital visual support (e.g. annotated images, visual summaries). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verbal information only | Behavioral | Verbal information only |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Reassurance Immediately Post-Consultation | Measured via a questionnaire. Hypothesis: Patients in the IntelliStudio group will report the highest levels of reassurance. | Through study completion, an average of 1 year |
| Knowledge of Personal Skin Cancer Risk | Assessed through a pre- and post-intervention knowledge questionnaire. Hypothesis: Personalized information (Groups B and C) improves risk awareness compared to standard care. | Through study completion, an average of 1 year |
| Confidence in Performing Self-Skin Checks | Measured via self-reported confidence and frequency of self-checks. Hypothesis: Groups B and C will report higher confidence than Group A. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
Low-risk skin cancer patients:
Adult subjects (between 18 years of age and 80 years) at time of enrolment
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annemiek Leeman, Prof. Dr. | Contact | 0032 16 33 79 50 | annemiek.leeman@uzleuven.be | |
| Sofie Van Kelst, Bsc. | Contact | 0032 16 33 78 64 | sofie.vankelst@kuleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZLeuven, Department of Dermatology | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Personalized Discharge Letter |
| Behavioral |
Personalized Discharge Letter: Tailored written information based on individual risk profile, skin type and consultation findings. |
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| Personalized Discharge Letter + IntelliStudio | Behavioral | Personalized Discharge Letter + IntelliStudio: Tailored written information plus digital visual support (e.g. annotated images, visual summaries). |
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